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As DTC Genetic Testing Grows Among Consumers, Insurers Are Beginning to Get on Board

Jaime Rosenberg
It's estimated that by 2021, 100 million people will have used a direct-to-consumer (DTC) genetic test. As these tests continue to gain popularity, there is a need for educating consumers on their DTC testing results and validating these results with confirmatory testing in a medical-grade laboratory.
As direct-to-consumer (DTC) testing gains momentum among consumers, there is a need for educating consumers on their DTC testing results and validating these results with confirmatory testing in a medical-grade laboratory. Spearheading this mission, My Gene Counsel, a digital health company that provides digital genetic counseling information, has formed a partnership with Ambry Genetics to offer a solution for these consumers. At the same time, insurers are warming up to the idea of covering confirmatory testing and seeing the benefits for their insured.

The program, meant for people with strong personal or family histories of cancer who have done a DTC test, offers patients a Living Lab Report explaining their DTC results and how they differ from a medical-grade test they may get through a genetic counselor or their provider. Patients then begin the verification process by providing their personal and family history of cancer, as well as their insurance information. From there, the program will begin to determine if the person would be covered for verification testing by their insurance, and if not, they discuss with the patient what their potential out-of-pocket costs would be.

Patients then speak with a certified genetic counselor by phone who helps them decide if they need verification testing, and if so, which one. If the consumer wishes to move forward with verification testing, a test kit is sent directly to their homes. After sending the kit back to Ambry Genetics, the consumer is provided with a final Living Lab Report from My Gene Counsel that explains their final test result that they can bring to their provider, and they can also opt for another counseling session by phone if they wish.

Recognition of a need for a program like this became evident as 23andMe gained FDA authorization of its DTC test that assesses 3 BRCA1/BRCA2 mutations that are most common in those of Ashkenazi Jewish descent. In January, the company also gained clearance for its DTC genetic test reporting on the 2 most common genetic variants associated with MUTYH-associated polyposis, a hereditary colorectal cancer syndrome. But 23andMe states that all of its results should be repeated in a medical-grade laboratory before medical decisions are made.

While rolling out the pilot, Ellen Matloff, MS, CGC, president and chief executive officer of My Gene Counsel, and her colleagues were met with the finding that many consumers have misconceptions about what these DTC tests offer.

“One of the things we found was that for some consumers who need help based on strong personal or family history, instead of getting medical-grade testing, they’re doing 23andMe and they’re using limited resources to pay for kits that won’t give them the answers they need,” said Matloff.

She gave the example of a woman participating in the program who had a strong personal history of breast cancer and a family history of ovarian cancer and had debated getting 23andMe kits for several members of her family to determine if they carried BRCA mutations. With the woman not being of Ashkenazi Jewish ancestry, the tests would have most likely come back negative for the 3 common Jewish BRCA mutations, giving the family false reassurance.

Even amongst those of Ashkenazi Jewish ancestry, a negative 23andMe BRCA test result is not the end of the story, as 23andMe’s test only releases the 3 most common BRCA mutations associated with the ancestry. Many people of Jewish ancestry with strong histories of cancer instead carry an uncommon mutation in BRCA, or a mutation in one of dozens of other cancer genes, which 23andMe does not return.


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